B-cell Chronic Lymphocytic LeukemiaPhase 1NCT01212380
Study of Carfilzomib in Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL) or Prolymphocytic Leukemia (PLL)
A Phase 1 study testing carfilzomib, Cytokine Assessment and Pharmacodynamic Studies in people with B-cell Chronic Lymphocytic Leukemia and Hematopoietic/Lymphoid Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and the best dose of carfilzomib in treating patients with relapsed or refractory chronic lymphocytic leukemia(CLL),small lymphocytic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Chronic Lymphocytic Leukemia, Hematopoietic/Lymphoid Cancer, Prolymphocytic Leukemia
- What is being tested?
- carfilzomib, Cytokine Assessment and Pharmacodynamic Studies
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Sep 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously treated patients with a diagnosis of chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or prolymphocytic leukemia (PLL) by NCI Criteria with intermediate or high risk B-Cell chronic lymphocytic leukemia (CLL)(Modified Rai stage) satisfying at least one of the criteria for active disease requiring treatment;patients with a history of Richter's transformation are eligible if they now have evidence of chronic lymphocytic leukemia (CLL) only, with < 10% large cells in the bone marrow
- Massive or progressive splenomegaly and/or lymphadenopathy; or need for cytoreduction for stem cell transplant
- Anemia (hemoglobin < 11 g/dl) or thrombocytopenia (platelets < 100 x 10^9/L)
- Presence of weight loss > 10% over the preceding 6 month period
- NCI grade 2 or 3 fatigue
- Fevers > 100.5 °C or night sweats for greater than 2 weeks without evidence of infection
Show all 15Show fewer
- Progressive lymphocytosis with an increase of > 50% over a 2 month period or an anticipated doubling time of less than 6 months
- Creatinine Clearance (CrCl) > 15mL/min
- Alanine aminotransferase (ALT) < 3X upper limit of normal (ULN)
- Bilirubin =< 2 times the upper limit of normal, unless disease related
- Platelets >= 20 x 10^9/L and absence of active bleeding
- Patients must have an ECOG (Eastern Cooperative Oncology Group) performance status =< 2
- Patients must not have secondary cancers that result in a life expectancy of <2 years or that would confound assessment of toxicity in this study
- Patients of all racial/ethnic groups are eligible for the study if they meet eligibility criteria outlined-
- Patients must provide written informed consent
Who cannot join
- Absence of previously treated chronic lymphocytic leukemia (CLL)
- Female subject that is pregnant or breastfeeding; women of childbearing potential and men must agree to use adequate contraception prior to study entry, duration of study participation,and 30 days following study completion; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately;confirmation that the subject is not pregnant must be established by a negative serum -human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
- Patients with congestive heart failure (CHF)in whom pre-treatment hydration would be prohibitive;New York Heart Association (NYHA) Class III/IV CHF is excluded
- Patients who have had treatment for chronic lymphocytic leukemia (CLL) within 2 weeks, although palliative steroids are acceptable
- Patient unable to give written informed consent
- Failure to recover from toxicity of previous radiotherapy or chemotherapy to grade 1
- Patients with active infections requiring intravenous (IV) antibiotic/antiviral therapy are not eligible for entry onto the study until resolution of the infection; patients on prophylactic antibiotics or antivirals are acceptable
- Patients who have previously taken bortezomib
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: A Phase I Study of Carfilzomib in Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)/Prolymphocytic Leukemia (PLL)
RATIONALE:
Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE:
This phase I trial is studying the side effects and the best dose of carfilzomib in treating patients with relapsed or refractory chronic lymphocytic leukemia(CLL),small lymphocytic lymphoma(SLL), or prolymphocytic leukemia (PLL).
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the dose limiting toxicity (DLT) and maximal tolerated dose (MTD) of carfilzomib in patients with relapsed or refractory Chronic Lymphocytic Leukemia(CLL) / Small Lymphocytic Lymphoma (SLL) and Prolymphocytic Leukemia (PLL).
II. To evaluate the safety and toxicity profile of carfilzomib in relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL)/prolymphocytic leukemia (PLL).
SECONDARY OBJECTIVES:
- To evaluate efficacy of carfilzomib therapy in relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL)/prolymphocytic leukemia (PLL) to justify future phase II studies.
II. To determine the degree and duration of cellular proteosome inhibition induced by carfilzomib and relationship of this to pharmacodynamics, response and toxicity.
III. To determine the pharmacokinetics (plasma and cellular) of carfilzomib and relationship of this to proteosome inhibition, pharmacodynamics, response, and toxicity.IV. To examine the effect of carfilzomib on pharmacodynamic parameters including cytokines, changes in downstream targets including NF-kappa B (p50/p65 binding; I-kappa B level, P-I-kappa B level,select target genes), p53 (p53 nuclear levels, p53 nuclear binding, and select target genes), ER stress proteins, and p73.
OUTLINE: This is a dose-escalation study of carfilzomib.Patients receiving carfilzomib intra-venous(IV) over 30 minutes once daily, on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
- Conditions
- B-cell Chronic Lymphocytic Leukemia, Hematopoietic/Lymphoid Cancer, Prolymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia
- Being tested
- carfilzomib, Cytokine Assessment, Pharmacodynamic Studies, Proteosome Inhibition Assessment, Pharmacogenomic Studies
- Keywords
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Hematologic Neoplasms, Leukemia, Prolymphocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carfilzomibDrug
Also called PR-171
Given IV infusion lasting 30 minutes. Will be administered IV at a specified dose in mg/m2 QDx2 weekly for 3 weeks (days 1, 2, 8, 9, 15, and 16). The first and second dose will always be administered at 20 mg/m2.
Cytokine AssessmentOther
Also called correlative studies
TNF-α,IFN-γ,IL-6,IL-8,IL-10,and IL-1β pre-dose, completion, 30 minutes, 2 hours, 6 hours, and approximately 24 hours from initiation of therapy on days 1 and 8 of treatment. These will be assessed utilizing standard ELISA or flow cytometry methodology. Other cytokines or soluble factors may be assessed that relate to drug toxicity or response. After 6 patients are examined in each group, the time points or number of cytokines examined may be changed to decrease time points examined. Cytokines will be examined by a multiplex flow cytometry assay or ELISA. Other cytokines, chemokines, or soluble factors may be assessed on residual material not used for these studies.
Pharmacodynamic StudiesOther
Also called correlative studies
Based upon our preliminary data changes occuring in vivo during carfilzomib treatment will be determined and if their occurrence correlates with both clinical response and development of cytokine release. These studies will be performed from CD19 selected CLL cells at screening, pre-treatment, 4 hours, and 24 hours post-therapy on days 1 and 8 of treatment; end of therapy evaluation, and at time of relapse (in responding patients). These studies will include assessment of NF-κB (p50/p65 binding; I-κB level, P-I-κB level, select target genes), p53 (p53 nuclear levels, p53 nuclear binding, and select target genes), p73, and ER stress response. Standard Western Blot, EMSA, RT-PCR will be done to complete these studies.
Proteosome Inhibition AssessmentOther
Also called pharmacological studies
Proteosome inhibition on CLL cells will be examined at screening, pre-treatment and post-treatment (immediately after completion of drug) days 1, pre-treatment day 2, day 3 (optional), day 5 (optional),pre and post-treatment days 8, pre and post-treatment days 9, day 10 (optional),day 12 (optional), and day 15 (optional).
Pharmacogenomic StudiesOther
Also called correlative studies
Germ line DNA from a buccal swab and bone marrow fibroblasts will be obtained at baseline screening for possible examination of SNP polymorphisms that may correlate with response and toxicity to carfilzomib therapy. Tumor DNA will be derived from samples obtained at baseline for the p53 mutational studies. SNPs related to drug metabolism, response, or toxicity to therapy, cytokine release, and tumor biology may be examined. Other SNPs may be used in the future. Given the potential for contamination in the recipient, recipient DNA from a buccal swab and/or saliva will be obtained at baseline screening for examination of SNP polymorphisms that may correlate with response, toxicity, and pharmacokinetics.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Patients receive carfilzomib IV over 30 minutes once daily on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.Performance of pharmacology, pharmacodynamic and pharmacogenomic studies allow assessment of carfilzomib mechanism of action and also to understand how the variability of these different features correlate with clinical benefit/response and also toxicity. Receives: Drug: carfilzomib; Other: Cytokine Assessment; Other: Pharmacodynamic Studies; Other: Proteosome Inhibition Assessment; Other: Pharmacogenomic Studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine safety of carfilzomib by evaluating the toxicity profile.
The safe use of carfilzomib will be assessed by:
- Determining the dose limiting toxicity and maximal tolerated dose of carfilzomib in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) and prolymphocytic leukemia (PLL)
- To evaluating the toxicity profile of carfilzomib in relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) and prolymphocytic leukemia (PLL)
Measured: Up to 24 months
Secondary outcomes (1)
To evaluate the efficacy of Carfilzomib therapy in relapsed or refractory chromic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL)/prolymphocytic leukemia (PLL)
Efficacy of this therapy is evaluated by:
- Determining the degree and duration of cellular proteosome inhibition and relationship to pharmacodynamic (PD), response and toxicity.
- Determining the pharmacokinetics(plasma and cellular)of carfilzomib and relationship to proteosome inhibition, PD, response and toxicity.
- Examining the effect of carfilzomib on PD parameters, changes in downstream targets including NFkB (p50/p65 binding;IkB level, P-IkB level, select target genes), p53 (p53 nuclear levels, p53 nuclear binding, and select target genes), ER stress proteins, and p73
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionJul 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Principal investigator, Jennifer Woyach, Ohio State University Comprehensive Cancer Center
- Investigators
- Jennifer Woyach, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212380
- Sponsor's protocol ID
- OSU-09108
- Other IDs
- NCI-2010-01884
- Status last verified
- May 2016
- First submitted
- 10 Sep 2010
- Last updated
- 9 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Carfilzomib in Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)/Prolymphocytic Leukemia (PLL)
- ClinicalTrials.gov ID
- NCT01212380
- Acronym / sponsor ID
- OSU-09108
- Conditions
- B-cell Chronic Lymphocytic Leukemia, Hematopoietic/Lymphoid Cancer, Prolymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia
- Keywords
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Oct 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 30 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE:
Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE:
This phase I trial is studying the side effects and the best dose of carfilzomib in treating patients with relapsed or refractory chronic lymphocytic leukemia(CLL),small lymphocytic lymphoma(SLL), or prolymphocytic leukemia (PLL).
Detailed description
PRIMARY OBJECTIVES:
- To determine the dose limiting toxicity (DLT) and maximal tolerated dose (MTD) of carfilzomib in patients with relapsed or refractory Chronic Lymphocytic Leukemia(CLL) / Small Lymphocytic Lymphoma (SLL) and Prolymphocytic Leukemia (PLL).
II. To evaluate the safety and toxicity profile of carfilzomib in relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL)/prolymphocytic leukemia (PLL).
SECONDARY OBJECTIVES:
- To evaluate efficacy of carfilzomib therapy in relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL)/prolymphocytic leukemia (PLL) to justify future phase II studies.
II. To determine the degree and duration of cellular proteosome inhibition induced by carfilzomib and relationship of this to pharmacodynamics, response and toxicity.
III. To determine the pharmacokinetics (plasma and cellular) of carfilzomib and relationship of this to proteosome inhibition, pharmacodynamics, response, and toxicity.IV. To examine the effect of carfilzomib on pharmacodynamic parameters including cytokines, changes in downstream targets including NF-kappa B (p50/p65 binding; I-kappa B level, P-I-kappa B level,select target genes), p53 (p53 nuclear levels, p53 nuclear binding, and select target genes), ER stress proteins, and p73.
OUTLINE: This is a dose-escalation study of carfilzomib.Patients receiving carfilzomib intra-venous(IV) over 30 minutes once daily, on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: carfilzomib, Other: Cytokine Assessment, Other: Pharmacodynamic Studies, Other: Proteosome Inhibition Assessment, Other: Pharmacogenomic StudiesPatients receive carfilzomib IV over 30 minutes once daily on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.Performance of pharmacology, pharmacodynamic and pharmacogenomic studies allow assessment of carfilzomib mechanism of action and also to understand how the variability of these different features correlate with clinical benefit/response and also toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Previously treated patients with a diagnosis of chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or prolymphocytic leukemia (PLL) by NCI Criteria with intermediate or high risk B-Cell chronic lymphocytic leukemia (CLL)(Modified Rai stage) satisfying at least one of the criteria for active disease requiring treatment;patients with a history of Richter's transformation are eligible if they now have evidence of chronic lymphocytic leukemia (CLL) only, with < 10% large cells in the bone marrow
- Massive or progressive splenomegaly and/or lymphadenopathy; or need for cytoreduction for stem cell transplant
- Anemia (hemoglobin < 11 g/dl) or thrombocytopenia (platelets < 100 x 10^9/L)
- Presence of weight loss > 10% over the preceding 6 month period
- NCI grade 2 or 3 fatigue
Key exclusion criteria (8 listed)
- Absence of previously treated chronic lymphocytic leukemia (CLL)
- Female subject that is pregnant or breastfeeding; women of childbearing potential and men must agree to use adequate contraception prior to study entry, duration of study participation,and 30 days following study completion; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately;confirmation that the subject is not pregnant must be established by a negative serum -human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
- Patients with congestive heart failure (CHF)in whom pre-treatment hydration would be prohibitive;New York Heart Association (NYHA) Class III/IV CHF is excluded
- Patients who have had treatment for chronic lymphocytic leukemia (CLL) within 2 weeks, although palliative steroids are acceptable
- Patient unable to give written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carfilzomibAlso: PR-171Given IV infusion lasting 30 minutes. Will be administered IV at a specified dose in mg/m2 QDx2 weekly for 3 weeks (days 1, 2, 8, 9, 15, and 16). The first and second dose will always be administered at 20 mg/m2. | Drug | Arm 1 |
| Cytokine AssessmentAlso: correlative studiesTNF-α,IFN-γ,IL-6,IL-8,IL-10,and IL-1β pre-dose, completion, 30 minutes, 2 hours, 6 hours, and approximately 24 hours from initiation of therapy on days 1 and 8 of treatment. These will be assessed utilizing standard ELISA or flow cytometry methodology. Other cytokines or soluble factors may be assessed that relate to drug toxicity or response. After 6 patients are examined in each group, the time points or number of cytokines examined may be changed to decrease time points examined. Cytokines will be examined by a multiplex flow cytometry assay or ELISA. Other cytokines, chemokines, or soluble factors may be assessed on residual material not used for these studies. | Other | Arm 1 |
| Pharmacodynamic StudiesAlso: correlative studiesBased upon our preliminary data changes occuring in vivo during carfilzomib treatment will be determined and if their occurrence correlates with both clinical response and development of cytokine release. These studies will be performed from CD19 selected CLL cells at screening, pre-treatment, 4 hours, and 24 hours post-therapy on days 1 and 8 of treatment; end of therapy evaluation, and at time of relapse (in responding patients). These studies will include assessment of NF-κB (p50/p65 binding; I-κB level, P-I-κB level, select target genes), p53 (p53 nuclear levels, p53 nuclear binding, and select target genes), p73, and ER stress response. Standard Western Blot, EMSA, RT-PCR will be done to complete these studies. | Other | Arm 1 |
| Proteosome Inhibition AssessmentAlso: pharmacological studiesProteosome inhibition on CLL cells will be examined at screening, pre-treatment and post-treatment (immediately after completion of drug) days 1, pre-treatment day 2, day 3 (optional), day 5 (optional),pre and post-treatment days 8, pre and post-treatment days 9, day 10 (optional),day 12 (optional), and day 15 (optional). | Other | Arm 1 |
| Pharmacogenomic StudiesAlso: correlative studiesGerm line DNA from a buccal swab and bone marrow fibroblasts will be obtained at baseline screening for possible examination of SNP polymorphisms that may correlate with response and toxicity to carfilzomib therapy. Tumor DNA will be derived from samples obtained at baseline for the p53 mutational studies. SNPs related to drug metabolism, response, or toxicity to therapy, cytokine release, and tumor biology may be examined. Other SNPs may be used in the future. Given the potential for contamination in the recipient, recipient DNA from a buccal swab and/or saliva will be obtained at baseline screening for examination of SNP polymorphisms that may correlate with response, toxicity, and pharmacokinetics. | Other | Arm 1 |
Primary outcome
Determine safety of carfilzomib by evaluating the toxicity profile.
Time frame: Up to 24 months
The safe use of carfilzomib will be assessed by: * Determining the dose limiting toxicity and maximal tolerated dose of carfilzomib in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) and prolymphocytic leukemia (PLL) * To evaluating the toxicity profile of carfilzomib in relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) and prolymphocytic leukemia (PLL)
1 secondary outcome
To evaluate the efficacy of Carfilzomib therapy in relapsed or refractory chromic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL)/prolymphocytic leukemia (PLL)
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
- JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Woyach, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing carfilzomib, Cytokine Assessment and Pharmacodynamic Studies in people with B-cell Chronic Lymphocytic Leukemia and Hematopoietic/Lymphoid Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine safety of carfilzomib by evaluating the toxicity profile. (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2016.